Hypertension, EssentialPhase 1NCT01227603
Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions
A Phase 1 study testing Nifedipine-candesartan FDC (BAY 98-7106), Nifedipine GITS (Adalat LA, BAYA1040) and Candesartan (Atacand) in people with Hypertension, Essential, run by Bayer at 1 site in Germany.
Trial summary
Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Essential
- What is being tested?
- Nifedipine-candesartan FDC (BAY 98-7106), Nifedipine GITS (Adalat LA, BAYA1040) and Candesartan (Atacand)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject
- Age: 18 to 45 years (inclusive) at the first screening / examination visit
- Ethnicity: Caucasian
- Body mass index (BMI): >/=18 and </=29,9 kg/m²
Who cannot join
- Systolic blood pressure below 120 or above 145 mmHg
- Diastolic blood pressure above 95 mmHg
- Heart rate below 45 or above 95 beats / min
- Clinically relevant findings in the physical examination
- Suspicion of drug or alcohol abuse
- Regular daily consumption of more than 1 L of xanthin-containing beverages
- Intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design
Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs
- Conditions
- Hypertension, Essential
- Being tested
- Nifedipine-candesartan FDC (BAY 98-7106), Nifedipine GITS (Adalat LA, BAYA1040), Candesartan (Atacand)
- Keywords
- Bioequivalence, Nifedipine, Candesartan, FDC
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine-candesartan FDC (BAY 98-7106)Drug
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
Nifedipine GITS (Adalat LA, BAYA1040)Drug
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Candesartan (Atacand)Drug
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine-candesartan FDC | Experimental | Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally. Receives: Drug: Nifedipine-candesartan FDC (BAY 98-7106) |
| Nifedipine and candesartan | Active comparator | Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally. Receives: Drug: Nifedipine GITS (Adalat LA, BAYA1040); Drug: Candesartan (Atacand) |
| Nifedipine | Active comparator | Each subject received one dose of nifedipine GITS 60 mg orally. Receives: Drug: Nifedipine GITS (Adalat LA, BAYA1040) |
| Candesartan | Active comparator | Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally. Receives: Drug: Candesartan (Atacand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Measured: Within 48 hours after each treatment
AUC(0-tn)
AUC from time 0 to the last data point for nifedipine and candesartan
Measured: Within 48 hours after each treatment
Secondary outcomes (9)
AUC
Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan
Measured: Within 48 hours after each treatment
Cmax,norm
Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan
Measured: Within 48 hours after each treatment
AUCnorm
Area under the curve divided by dose per kg body weight for nifedipine and candesartan
Measured: Within 48 hours after each treatment
AUC(0-48)
AUC from time 0 to time 48 h for nifedipine and candesartan
Measured: Within 48 hours after each treatment
tmax
Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan
Measured: Within 48 hours after each treatment
t½
Half-life associated with the terminal slope for nifedipine and candesartan
Measured: Within 48 hours after each treatment
MRT
Mean residence time for nifedipine and candesartan
Measured: Within 48 hours after each treatment
CL/f
Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan
Measured: Within 48 hours after each treatment
Number of participants with adverse events
Measured: Approximately 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, EssentialStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227603
- Sponsor's protocol ID
- 14027
- Other IDs
- 2010-021966-31
- Status last verified
- Dec 2015
- First submitted
- 22 Oct 2010
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brendel E, Weimann B, Dietrich H, Froede C, Thomas D. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions. Int J Clin Pharmacol Ther. 2013 Sep;51(9):753-62. doi: 10.5414/CP201879.
PubMed 23849325
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design
- ClinicalTrials.gov ID
- NCT01227603
- Acronym / sponsor ID
- 14027
- Conditions
- Hypertension, Essential
- Keywords
- Bioequivalence, Nifedipine, Candesartan, FDC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nifedipine-candesartan FDC | Experimental | Drug: Nifedipine-candesartan FDC (BAY 98-7106)Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally. |
| Nifedipine and candesartan | Active comparator | Drug: Nifedipine GITS (Adalat LA, BAYA1040), Drug: Candesartan (Atacand)Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally. |
| Nifedipine | Active comparator | Drug: Nifedipine GITS (Adalat LA, BAYA1040)Each subject received one dose of nifedipine GITS 60 mg orally. |
| Candesartan | Active comparator | Drug: Candesartan (Atacand)Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subject
- Age: 18 to 45 years (inclusive) at the first screening / examination visit
- Ethnicity: Caucasian
- Body mass index (BMI): >/=18 and </=29,9 kg/m²
Key exclusion criteria (7 listed)
- Systolic blood pressure below 120 or above 145 mmHg
- Diastolic blood pressure above 95 mmHg
- Heart rate below 45 or above 95 beats / min
- Clinically relevant findings in the physical examination
- Suspicion of drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine-candesartan FDC (BAY 98-7106)Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan | Drug | Nifedipine-candesartan FDC |
| Nifedipine GITS (Adalat LA, BAYA1040)Single oral dose of 1 tablet of nifedipine GITS 60 mg | Drug | Nifedipine, Nifedipine and candesartan |
| Candesartan (Atacand)Single oral dose of 32 mg (2 x 16 mg tablet) candesartan | Drug | Candesartan, Nifedipine and candesartan |
Primary outcome
Cmax
Time frame: Within 48 hours after each treatment
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
AUC(0-tn)
Time frame: Within 48 hours after each treatment
AUC from time 0 to the last data point for nifedipine and candesartan
9 secondary outcomes
AUC
Time frame: Within 48 hours after each treatment
Cmax,norm
Time frame: Within 48 hours after each treatment
AUCnorm
Time frame: Within 48 hours after each treatment
AUC(0-48)
Time frame: Within 48 hours after each treatment
tmax
Time frame: Within 48 hours after each treatment
t½
Time frame: Within 48 hours after each treatment
MRT
Time frame: Within 48 hours after each treatment
CL/f
Time frame: Within 48 hours after each treatment
Number of participants with adverse events
Time frame: Approximately 3.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Results publication: PubMed 23849325Brendel E, Weimann B, Dietrich H, Froede C, Thomas D. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions. Int J Clin Pharmacol Ther. 2013 Sep;51(9):753-62. doi: 10.5414/CP201879.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nifedipine-candesartan FDC (BAY 98-7106), Nifedipine GITS (Adalat LA, BAYA1040) and Candesartan (Atacand) in people with Hypertension, Essential, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Within 48 hours after each treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01227603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.